510(k) · Cleared

Recalled · Class II · 2018

NeuViz 16 Essence Multi-slice CT Scanner System

K171198510(k) TraditionalCleared Dec 7, 2017227-day reviewClass II21 CFR 892.1750Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Neusoft Medical Systems Co., Ltd. · JAK System, X-Ray, Tomography, Computed

Cleared on Dec 7, 2017 as substantially equivalent to K092742 (Neusoft Medical Systems Co., Ltd., 2009) after a 227-day review. Its family tree reaches back 1 generation to 2009. It has been recalled once.

Decided: Dec 7, 2017
Review: 227 days
Class: Class II
Product code: JAK
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K092742 (2009). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK092742 Neuviz 16 Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2009 · Recalled
This deviceK171198 NeuViz 16 Essence Multi-slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2017

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K092742	Neuviz 16 Multi-Slice CT Scanner System	Neusoft Medical Systems Co., Ltd.	2009	5
0 (this device)	K171198	NeuViz 16 Essence Multi-slice CT Scanner System	Neusoft Medical Systems Co., Ltd.	2017	—

FIG. 1 — Lineage of K171198, 2009–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JAK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JAK device

#1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K092742	Neuviz 16 Multi-Slice CT Scanner System Summary page 4 …X-ray Equipment Standard Primary Predicate device: Trade Name: NeuViz 16 Multi-Slice CT Scanner System 510(k) number: K092742 Clearance Date: 09/22/2009 Regulation: 21 CFR 892.1750 Classification Name: Computed tomography x-ra…	Neusoft Medical Systems Co., Ltd.	2009	5
†	K151383	NeuViz 128 Multi-slice CT Scanner System	Neusoft Medical Systems Co., Ltd.	2015	3
†	K133373	Clearview	Neusoft Medical Systems Co., Ltd.	2014	—

Also cleared against K092742: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 22, 2018	Class II	Z-1281-2019	Software design	Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
1 other device also cites its predicate K092742.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · JAK

27in 2025

2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007high 200 (2014) · low 27 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JAK

17in 2025

2007high 51 (2010) · low 5 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAK

219in 2025

2007high 543 (2018) · low 76 (2007)2025

MAUDE reports naming product code JAK, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	14	27	11	76
2008	26	42	16	120
2009	15	31	29	105
2010	7	92	51	119
2011	16	155	34	205
2012	28	121	23	192
2013	17	132	11	414
2014	30	200	10	308
2015	30	140	28	454
2016	25	129	44	365
2017	29	96	33	338
2018	24	114	10	543
2019	28	94	5	233
2020	30	112	8	177
2021	20	145	15	261
2022	30	131	9	199
2023	27	139	9	310
2024	26	141	20	212
2025	27	141	17	219
2026	21	167	23	—

What is it indicated for?

The NeuViz 16 Essence Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K171198 · printed Nov 5, 2026

Cite this page

510(k) Report. “K171198: NeuViz 16 Essence Multi-slice CT Scanner System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K171198

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026